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NCT07384572

Perioperative Recovery Outcomes With a Spontaneous Breathing Strategy in Severely Underweight Lung Transplant Recipients

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

The goal of this prospective, multicenter, single-arm clinical study is to learn whether a spontaneous breathing-preserving perioperative management strategy can improve recovery and is safe in lung transplant recipients with very low body weight (body mass index \[BMI\] \<16 kg/m²). The main questions it aims to answer are whether, in lung transplant recipients with very low body weight (BMI \<16 kg/m²), a spontaneous breathing-preserving anesthesia-surgical strategy combined with standardized nutritional optimization and a prehabilitation program can improve early postoperative recovery and perioperative survival. Specifically, the study will assess the proportion of participants who require postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival within the protocol-defined time window (e.g., through hospital discharge). Participants will undergo lung transplantation using a perioperative strategy that preserves spontaneous breathing whenever clinically appropriate, with predefined criteria for conversion to endotracheal intubation and mechanical ventilation if needed. They will receive standard postoperative monitoring and supportive care, with respiratory support events and perioperative complications assessed during the index hospitalization (and up to 30 days after surgery, if specified in the protocol). Key outcomes will be collected from routine clinical care, including postoperative ventilatory support status, length of hospital stay, and major safety events.

Official title: Evaluation of Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Severely Underweight Lung Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-13

Completion Date

2029-01-30

Last Updated

2026-02-03

Healthy Volunteers

Conditions

End-stage Lung Disease

Interventions

PROCEDURE

Lung transplantation that preserves spontaneous breathing function

This intervention uses a spontaneous-breathing-preserving anesthesia strategy during lung transplantation, which differs from conventional management based on endotracheal intubation and invasive mechanical ventilation. A supraglottic airway (laryngeal mask airway) is used when feasible instead of endotracheal intubation to maintain spontaneous breathing throughout the procedure. Neuromuscular blocking agents are minimized, and regional nerve blocks (such as intercostal nerve blocks or paravertebral blocks) are used to control pain and suppress cough while preserving the patient's ability to breathe independently. After surgery, patients receive protocol-guided noninvasive respiratory support (for example, high-flow nasal oxygen or noninvasive ventilation), with the goal of avoiding routine invasive mechanical ventilation.

\[1\] Inclusion Criteria 1. Age and informed consent: Age ≥18 years; able to understand the study and provide written informed consent; willing and able to comply with follow-up. 2. Transplant candidacy: Listed in CLuTR or the participating center's lung transplant waiting list and scheduled to undergo allogeneic lung transplantation. 3. Low body weight definition (core cohort criterion): Preoperative BMI \<16 kg/m², calculated using the most recent traceable preoperative height and weight within the evaluation window. 4. Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) and not on ECMO or other extracorporeal life support preoperatively. 5. Minimum acceptable end-organ function: LVEF ≥40%; eGFR ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; American Society of Anesthesiologists (ASA) physical status ≤ IV. 6. Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meeting center transplant requirements (e.g., undetectable viral load, where applicable). 7. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver). \[2\] Exclusion Criteria 1. Consent/compliance: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or presence of recurrent severe non-adherence. 2. Transplant type: Retransplantation, multi-organ transplantation, or planned lobar lung transplantation. 3. Recent major cardiovascular/cerebrovascular events: Acute coronary syndrome/myocardial infarction or stroke within the past 30 days. 4. Severe organ dysfunction/acute failure: LVEF \<40%; eGFR \<40 mL/min/1.73 m²; acute liver failure or decompensated cirrhosis/portal hypertension; acute renal failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorder or altered mental status. 5. High-risk/severe infection: Septic shock; active extrapulmonary or disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting center transplant standards). 6. High bleeding risk: Severe bronchiectasis not treated with preoperative vascular intervention or not readily correctable. 7. Malignancy: Active malignancy or malignancy with high risk of recurrence or cancer-related mortality. 8. Severe chest wall or spinal deformity: Definitively diagnosed severe thoracic cage deformity or spinal deformity. 9. Substance use/dependence: Current use of cigarettes, e-cigarettes, inhaled cannabis, or intravenous drugs. 10. Tubeless/spontaneous breathing-preserving strategy not safely feasible: Determined by the anesthesia team to have a difficult airway or unsafe supraglottic/non-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal/laryngeal narrowing not suitable for a laryngeal mask airway), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomic variants (e.g., aberrant right upper lobe bronchial takeoff in a planned right lung transplant) deemed difficult to manage safely with an LMA or single-lumen tube. 11. Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology deemed unacceptable by the transplant team. 12. Protected populations: Pregnant or breastfeeding women.